Metal Ion Levels in Stryker Trident II Tritanium System with Modular Dual Mobility (MDM) Liner, Ceramic Head, and SecurFit Advanced Stems

NCT03433742 | Completed FDA Device

• 1 other identifier: 2017-1567
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Metal Ions levels of cobalt, chromium, and titanium in 40 patients preoperatively and at least 1 year status post total hip replacement with the Trident II Tritatnium system using an MDM liner and ceramic head. Are cobalt, chromium, and titanium levels in patients who undergo a total hip replacement with a Trident II Tritanium system, MDM liner, and ceramic head normal one year after surgery? Investigators expect to find normal levels of metal ions (cobalt, chromium, and titanium) after total hip replacement using Trident II Tritanium cups with an MDM liner and a ceramic head. The primary outcome (PO) is blood metal ion levels of cobalt, chromium, and titanium (concentration of metal ions in blood). Blood will be drawn in the 3rd Floor West of the Main Building, and then tested for metal ions in the Hospital for Special Surgery laboratory. The bloods will be drawn at a preoperative visit and at a one year visit.

Conditions

Hip Pain

Keywords

metal ion levels, total hip replacement, Trident II cup.

Outcome Measures

Primary Outcomes (1)

• Metal Ion levels before and 1 year after a total hip replacement with a Trident II Cup

  The primary outcome (PO) is blood metal ion levels of cobalt, chromium, and titanium (concentration of metal ions in blood). Blood will be drawn in the 3rd Floor West of the Main Building, and then tested for metal ions in the Hospital for Special Surgery laboratory.

  1 year

Study Arms (2)

Preoperative Group

OTHER

This is a group of 30 patients who will be undergoing a total hip replacement with a Trident II shell. This group of patients will have their bloods drawn and tested for metal ion levels at a preoperative visit.

Other: Blood levels drawn

1 year Postoperative Group

OTHER

This is the same group of 30 patients who are now one year post op after having a total hip replacement with a Trident II shell. This group of patients will have their bloods drawn and tested for metal ion levels at their one year visit.

Other: Blood levels drawn

Interventions

Blood levels drawn OTHER

The patients will have their bloods drawn at the Hospital for Special Surgery during their regular, standard of care visit. The laboratory at the Hospital for Special Surgery will then test their bloods to determine the metal ion levels.

1 year Postoperative Group; Preoperative Group

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who will be undergoing a total hip replacement with a Stryker Trident II cup
• Patients have signed an Institutional Review Board (IRB) approved consent form
• Patient is 21-80
• Patient has a diagnosis of Non-Inflammatory Degenerative Joint Disease
• Patient is willing and able to comply with postoperative scheduled clinical evaluations.

You may not qualify if:

• Patients who have not been consented as part of the Collaborative Orthopaedic Replacement Registry (CORRe) database
• Patients with other joint replacements (shoulder/knee)
• Patients with bilateral hip replacements
• Prisoners
• International Patients

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead
• Stryker Nordic: collaborator

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: February 15, 2018
• Study Start: February 22, 2018
• Primary Completion: January 11, 2024
• Study Completion: January 11, 2024
• Last Updated: March 17, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)